Comparison of the effectiveness of two treatment protocols dexmedetomidine - propofol and midazolam - fentanyl - propofol in relieving pain in patients undergoing lithotomy
Determining the comparison of the efficacy of two treatment protocols, dexmedetomidine-propofol and midazolam-fentanyl-propofol, in relieving pain in patients undergoing surgery
Design
A controlled, parallel-group, double-blind, randomized, phase 2 clinical trial on 40 patients. The Sealed Envelope website was used for randomization.
Settings and conduct
Subject referral patients in the stone lithotripsy ward of Ganjovian Hospital, Dezful are randomly placed in the group and at the beginning of the study and one week after the start of the study, the level of Substance P is measured and compared with another.
Participants/Inclusion and exclusion criteria
Patients with kidney stones below 2cm and proximal ureter for ESWL aged 18 to 80 years with American Society of Anesthesiologists (ASA) physical status I, II or III who consent to participate in this study will be eligible for this study.
Patients who do not agree to participate in this study
Patients with chronic liver failure
Patients who have a history of allergy to this drug or other alpha-adrenergic drugs
Patients with a history of bradycardia and low blood pressure
Patients with coagulation disorders
Patients with a history of allergy to drugs used to treat ESWL
Patients with mental disorders, nervous disorders and skin disorders (inflammation).
Patients with active infection
Patients who are pregnant
Patients who have uremia
Patients with BMI>25
Patients who have used painkillers 12 hours before visiting
Patients who have pain before visiting
Intervention groups
Intervention group: dexmedetomidine-propofol, control group: midazolam-propofol
Main outcome variables
Plasma level of Substance P in patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230701058625N1
Registration date:2023-10-11, 1402/07/19
Registration timing:registered_while_recruiting
Last update:2023-10-11, 1402/07/19
Update count:0
Registration date
2023-10-11, 1402/07/19
Registrant information
Name
Mehdi Rajaeipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 916 641 0103
Email address
mehdi.rajaeipour@dums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-02, 1402/07/10
Expected recruitment end date
2024-04-12, 1403/01/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of two treatment protocols dexmedetomidine - propofol and midazolam - fentanyl - propofol in relieving pain in patients undergoing lithotomy
Public title
Comparing the effectiveness of two treatment protocols: dexmedetomidine - propofol and midazolam - fentanyl - propofol in relieving pain in patients undergoing extracorporeal stone crusher
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with kidney stones below 2cm and proximal ureter for ESWL aged 18 to 80 years with American Society of Anesthesiologists (ASA) physical status I, II or III who consent to participate in this study will be eligible for this study.
Exclusion criteria:
Patients who do not agree to participate in this study
Patients with chronic liver failure
Patients who have a history of allergy to this drug or other alpha-adrenergic drugs
Patients with a history of bradycardia and low blood pressure
Patients with coagulation disorders
Patients with a history of allergy to drugs used to treat ESWL
Patients with mental disorders, nervous disorders and skin disorders (inflammation).
Patients with active infection
Patients who are pregnant
Patients who have uremia
Patients with BMI > 25
Patients who have used painkillers 12 hours before visiting
Patients who have pain before visiting
Age
From 18 years old to 80 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
40 patients who meet the criteria will enter the study and will be divided into two groups of 20 using computer random numbers. Group A, dexmedetomidine (a vial CC2mcg/200 diluted with CC50 normal saline and infused over 10 minutes.
Blinding (investigator's opinion)
Double blinded
Blinding description
A nurse anesthetist who is not involved in this study will inject the drugs to the patients, then before and three hours after the operation, a blood sample will be taken by the researcher to measure P-Substance. None of the patients, as well as the researcher, will know what medicine was used for each patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Dezful University of Medical Sciences
Street address
Justice corner, Post St., 15 Khordad Blvd., Dezful
City
Dezfoul
Province
Khouzestan
Postal code
6461669969
Approval date
2023-05-09, 1402/02/19
Ethics committee reference number
IR.DUMS.REC.1402.015
Health conditions studied
1
Description of health condition studied
Patients with Calculus of kidney
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney
Primary outcomes
1
Description
Plasma level of Substance P in patients
Timepoint
At the beginning of the study and one week after lithotomy of the patients
Method of measurement
Measuring the Plasma level with ELISA
2
Description
Pain
Timepoint
At the beginning of the study and one week after lithotomy of the patients
Method of measurement
The person is shown a scale from 0 to 10 and the person gives a score from 0 to 10 on the level of pain felt. (Visual Analogue Scale)
Secondary outcomes
1
Description
Blood pressure
Timepoint
Two times, before ESWL and one week after ESWL
Method of measurement
Manual sphygmomanometer
2
Description
Respiratory rate
Timepoint
Two times, before ESWL and one week after ESWL
Method of measurement
clinical examination
3
Description
Nausea and Vomiting
Timepoint
Two times, before ESWL and one week after ESWL
Method of measurement
Event occur
Intervention groups
1
Description
Intervention group: Group A will receive dexmedetomidine (a vial CC2mcg/200 diluted with CC50 normal saline and infused over 10 minutes. This form of infusion will be repeated if needed) and propofol (0.5 mg/kg)
Category
Treatment - Drugs
2
Description
Intervention group: Group B will receive midazolam (0.025 mg/kg), fentanyl (1 mcg/kg) and propofol (0.5 mg/kg).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dezful Ganjavian Hospital stone crusher department
Full name of responsible person
Mehdi Rajaeipour
Street address
Justice corner, Post St., 15 Khordad Blvd., Dezful
City
Dezfoul
Province
Khouzestan
Postal code
6461669969
Phone
+98 61 4242 8717
Email
mehdi.rajaeipour@dums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dezfoul University of Medical Sciences
Full name of responsible person
Mohammad Amin Bahmanesh
Street address
Justice corner, Post St., 15 Khordad Blvd., Dezful
City
Dezfoul
Province
Khouzestan
Postal code
6461653476
Phone
+98 916 641 0103
Email
mehdi.rajaeipour@dums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dezfoul University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Dezfoul University of Medical Sciences
Full name of responsible person
Mehdi Rajaeipour
Position
Assistant Professor of Urology
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Justice corner, Post St., 15 Khordad Blvd., Dezful
City
Dezfoul
Province
Khouzestan
Postal code
6461669969
Phone
+98 916 641 0103
Fax
Email
mehdi.rajaeipour@dums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dezfoul University of Medical Sciences
Full name of responsible person
Mehdi Rajaeipour
Position
Assistant Professor of Urology
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Justice corner, Post St., 15 Khordad Blvd., Dezful
City
Dezfoul
Province
Khouzestan
Postal code
6461669969
Phone
+98 916 641 0103
Fax
Email
mehdi.rajaeipour@dums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Dezfoul University of Medical Sciences
Full name of responsible person
Mehdi Rajaeipour
Position
Assistant Professor of Urology
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Justice corner, Post St., 15 Khordad Blvd., Dezful
City
Dezfoul
Province
Khouzestan
Postal code
6461669969
Phone
+98 916 641 0103
Fax
Email
mehdi.rajaeipour@dums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available